# K992218: Disposable Irrigation Bipolar Cord Assembly for Malis System CMC-II, Model 10-4601

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Jul 30, 1999 after 29 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set: named in the summary without a submission number
- (no number) NUI1060, Irrigation / Bipolar Set, for Malis System CMC-II: named in the summary without a submission number

## Indications for use
The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC®-Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMCE-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

Source page: https://510kreport.com/device/K992218
Methodology: https://510kreport.com/methodology